Orteronel Plus Prednisone Fails to Improve Survival in Metastatic Castration-Resistant Prostate Cancer
the Cancer Therapy Advisor take:
According to a new study published in the journal The Lancet Oncology, researchers have found that the combination of orteronel and prednisone improved progression-free survival, but not overall survival, in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) compared with placebo plus prednisone.
For this double-blind, placebo-controlled, phase 3 study, researchers enrolled 1,560 patients with chemotherapy-naive mCRPC and randomly assigned them 1:1 to receive either orteronel 400mg plus prednisone 5mg twice daily or placebo plus prednisone 5mg twice daily.
Results showed that with a median follow-up of 8.4 months, the median radiographic progression-free survival was 13.8 months (95% CI: 13.1 - 14.9) and 8.7 months (8.3 - 10.9) with orteronel and prednisone, respectively (HR = 0.71; 95% CI: 0.63 - 0.80; P < 0.0001). In addition, with a median follow-up of 20.7 months, the median overall survival was 31.4 months (95% CI: 28.6 - NE) with orteronel compared with 29.5 months (27.0 - NE) with placebo (HR = 0.92; 95% CI: 0.79 - 1.08; P = 0.31).
Orteronel plus prednisone was also associated with increased toxicity versus placebo prednisone. The negative findings have led to the discontinuation of development of orteronel for mCRPC.
Combination orteronel and prednisone did not improve overall survival in mCRPC.
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|
|Renal Cell Carcinoma||Regimens||Drugs|
Cancer Therapy Advisor Articles
- FDA Approves Ivosidenib for IDH1-Mutated Relapsed/Refractory Acute Myeloid Leukemia
- Clinical Stage at First Response May Predict Outcomes in Chronic Lymphocytic Leukemia
- Exercise and Cancer
- Increased Body Mass Index May Be Predictive of Recurrence, Progression in Bladder Cancer
- Aspirin, Non-Aspirin NSAID-Use May Improve Survival Outcomes in Ovarian Cancer